Kornimate/medical-research-clean huggingface dataset:
impact of perioperative organ resuscitation of brain-dead deceased organ donor on kidney graft function in the recipient

Conditions: Kidney Graft

Summary: brain-dead patients are the primary source of grafts for those awaiting organ transplantation. recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity. graft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors. through this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. for simplicity, the investigators will focus on kidney grafts. the aim is to improve the effectiveness of the transplant and reduce waiting times.


Eligibility criteria:
inclusion criteria: the inclusion criteria for organ donor patients are as follows: * adult patient * brain dead * hospitalized in surgical intensive care at strasbourg university hospital (nhc cardiovascular intensive care unit, nhc multi-purpose intensive care unit, hautepierre surgical intensive care unit) from january 1, 2018 to december 31, 2023 * having undergone multi-organ transplantation * at least one of the donor kidneys has been transplanted to a patient at strasbourg university hospital * absence of written objection in the medical file of the subject (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes. the inclusion criteria for kidney transplant recipients are as follows: * adult patient * recipient of a kidney transplant from an organ donor who meets the inclusion criteria for donor patients mentioned above * patient who has undergone surgery and is hospitalized post-operatively at strasbourg university hospital * patient monitored by the strasbourg university hospital transplant team * absence of written objection in the subject's medical file (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes. exclusion criteria: * subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes * brain-dead patient who has not undergone organ retrieval * brain-dead patient whose kidney has not been allocated to a recipient in strasbourg * patient transferred to the strasbourg university hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval * kidney transplant patient with a graft from a living donor * kidney transplant patient with a graft from a deceased donor who is not brain-dead * kidney transplant patient with a graft from a deceased donor who is brain-dead and hospitalized in a hospital other than strasbourg

Keywords: kidney graft grafts organ transplantation
pilot study of the safety and clinical efficacy of topical dermacyn™ wound care to treat mild diabetic foot infections

Conditions: Foot Ulcer, Diabetic

Summary: to compare the rates of clinical success of topical dermacyn™ vs. oral levofloxacin vs. combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.


Eligibility criteria:
inclusion criteria: * a patient must meet all of the following inclusion criteria to be enrolled in the study: 1. males and females \> 18 years of age with diabetes mellitus (type 1 or type 2, controlled). 2. presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by idsa guidelines and the utc / 1b. 3. foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy. 4. foot ulcers located in the plantar, dorsal or malleolar areas. 5. ulcers 1- 9 cm2 in size. 6. an accessible infection site for culture. 7. abi by doppler ≥ 0.8 or tcpo2 ≥ 30 mmhg. 8. palpable pulse on the study foot (either dorsalis or posterior tibial artery). 9. willing and able to give informed consent. 10. willing to comply with the requirements for participation in the study. exclusion criteria: patients are excluded if they meet any of the following criteria at the time of randomization: 1. previous antibiotic treatment received for more than 24 hours within 72 hours of study. 2. necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns. 3. superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis). 4. the patient´s ulcer is located on the stump of an amputated extremity. 5. the patient's ulcer is due to a non-diabetic etiology. 6. infections complicated by the presence of prosthetic materials. 7. osteomyelitis 8. females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding. 9. known to have liver disease, with total bilirubin \> 5 times the upper limit of normal (uln); known to have neutropenia (absolute neutrophil count \<500 cells/mm3). 10. hypersensitivity to chlorine or quinolones. 11. need for any additional concomitant systemic antibacterial agent other than the study drug(s). 12. concomitant glucocorticoid doses (\> 5mg prednisone a day or equivalent). 13. adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders. 14. a history of diseases of immune function (hiv, chronic granulomatous disease). 15. any medical condition that, in the investigator´s opinion, will require dose modification of levofloxacin to less than 750 mg a day. 16. has received an investigational agent ≤1 month prior to the baseline evaluation.

Keywords: diabetic ulcer infection topical wound
food security and perceptions and barriers to healthy eating in individuals with spinal cord injuries

Conditions: Spinal Cord Injuries

Summary: food security is one's ability to get food. individuals with a spinal cord injury (sci) have many risk factors for low rates of food security. some of these risk factors include lower levels of income and employment. our long-term goal is to identify if food security is more prevalent in the sci population, and to develop ways to improve food security in the sci population. the purpose of this study is to determine the rates of food insecurity in a sample of people living with a sci and to identify some perceptions of barriers to healthy eating in the sci population.

food security is one's ability to get food. individuals with a sci have many risk factors for low rates of food security. some of these risk factors include lower levels of income and employment. this study consists of a one-time survey using the us adult food security survey and another previously validated survey about perceptions of barriers to healthy eating. our long-term goal is to develop a large sci food security and perceived barriers to healthy eating multicenter study in order to determine if these factors are significant issues in the sci population. we also aim to determine the causes of these issues in order to develop interventions to improve the health of all people living with a sci and potentially reduce their health care costs. the purpose of this study is to determine the rates of food insecurity in a sample of people living with a sci and to identify some perceptions of barriers to healthy eating in the sci population. this will also develop preliminary data to support a nih r level grant application for a large, multicenter study to further explore sci food security at the national level. our central hypothesis is that there will be an increased rate of food insecurity in the sci population compared to other groups in the literature, and that this will be associated with income and environmental barriers.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * male or female, any ethnicity, with the history of a spinal cord injury at least one year prior (without a diagnosis of multiple sclerosis or malignant cancer) * community wheelchair user * voluntary, informed consent of participant and interest in participating in further research studies * lives in the community, not a skilled nursing facility exclusion criteria: * age \<18 years old * chronic, nontobacco substance-abuse * community ambulator
extracts of amla, walnut leaf, red yeast rice and olive in cardiovascular prevention

Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Summary: the aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (cholesfytol ng®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia 1. leads to a clinically relevant reduction of cholesterol levels, especially ldl, 2. leads to a clinically relevant reduction of blood pressure on the short term, 3. leads to a change in oxidative stress biomarkers. participants will be stratified by sex before randomization to one of the two treatments for 8 weeks: * cholesfytol ng: 500 mg amla dry extract, 50 mg walnut leaf dry extract, 33.6 mg red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day * placebo all treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). no dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. at baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, bmi and waist circumference are measured.


Eligibility criteria:
inclusion criteria: * ldl ≥ 130 mg/dl exclusion criteria: * \<18 jaar * \>76 jaar * smoking * use of nutritional supplements or (chronic) medication\* * triglycerides \> 400 mg/dl * \> 14 alcoholic consumptions/week * chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis) * acute infection * current pregnancy or pregnancy wish during the study period * breast feeding * when nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication. use of lipid lowering medication of food supplements is only permitted after a wash out period of at least 6 weeks.
flexible tip bougie catheter intubation

Conditions: Emergency Medicine; Endotracheal Intubation; Cardiopulmonary Arrest

Summary: we, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. we hypothesized that in the hands of experienced anesthesiologists the new flexible tip bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. in the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new flexible tip bougie catheter would prove superior to the standard bougie stylet.


Eligibility criteria:
inclusion criteria: * physicians * give voluntary consent to participate in the study * none experience in videolaryngoscopy * less than 1 year experience in medicine exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: endotracheal intubation emergency medicine cardiopulmonary resuscitation physician
safety and activity of sdx-105 (bendamustine) in patients with rituximab refractory non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: summary: as this is an open label study, all patients will receive sdx-105 by 30-60 minute intravenous infusion on day 1 and day 2. treatment will repeat every 21 days. treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. patients will be followed until disease progression. rationale: drugs used in chemotherapy, such as sdx-105, use different ways to stop tumor cells from dividing so they stop growing or die. purpose: this study will evaluate the effectiveness and safety in non-hodgkin's lymphoma in patients who are refractory to rituxan.


Eligibility criteria:
inclusion criteria: * documented indolent or transformed b-cell nhl indolent nhl: follicular b-cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma * documented refractory disease to rituximab therapy, given as a single agent or in combination (defined as no response, or progression within 6 months of completing rituximab treatment.) * age of at least 18 years at screening visit (site specific requirement may differ) exclusion criteria: * previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously. * use of investigational agents within 28 days of study * history of prior high dose chemotherapy with allogeneic stem cell support

Keywords: nhl, indolent nhl, non-hodgkin's lymphoma, lymphoma
prospective study on the feasibility and effectiveness of per-oral endoscopic myotomy (p.o.e.m.) for treatment of primary esophageal motility disorders

Conditions: Primary Esophageal Motility Disorders Including Achalasia and Hypertensive LES

Summary: rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. the commonest causes of spastic esophageal motility disorders included achalasia, hypertensive lower esophageal sphincter (les), nutcracker esophagus and diffuse esophageal spasm (des). majority of these diseases were diagnosed by manometry. achalasia is the most common primary esophageal motility disorder in which the les failed to relax with increased pressure. currently the standard treatment for achalasia and spastic motility disorders is laparoscopic myotomy. the development of natural orifices transluminal endoscopic surgery (n.o.t.e.s.) has lead to a new way to perform myotomy - peroral endoscopic myotomy (p.o.e.m.). basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.


Eligibility criteria:
inclusion criteria: * all patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. the primary motility disorders included: achalasia, hypertensive les, nutcracker esophagus and diffuse esophageal spasm. exclusion criteria: 1. pregnancy 2. informed consent not available 3. previous history of esophagectomy or mediastinal surgery 4. previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection 5. end-stage achalasia with dilated esophagus more than 6cm on barium swllow
the effect of lansoprazole in combination with ecabet sodium for gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: we will estimate the responses of lansoprazole and ecabet sodium combination therapy and compare with lansoprazole and placebo therapy in patients who need additional therapy after standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal reflux disease.


Eligibility criteria:
inclusion criteria: * age 19-75 years * patients with typical gastroesophageal symptom or erosive reflux esophagitis on gastroduodenoscopy * patients with recurrent gastroesophageal symptom after standard proton pump inhibitor treatment for 4 weeks or more exclusion criteria: * patients with gastric ulcer or duodenal ulcer * patients with gastric cancer or esophageal cancer * pregnant or postpartum women

Keywords: gastroesophageal reflux disease lansoprazole ecabet sodium
safety study of an adjuvanted candidate influenza vaccine to prevent influenza disease in the elderly population

Conditions: Influenza

Summary: as influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current glaxosmithkline fluarix™ influenza vaccine in elderly subjects. the purpose of this study is to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted glaxosmithkline influenza vaccine administered intramuscularly about 1 year after administration of the first dose of vaccine. for immunogenicity and safety evaluations, subjects who have already received fluarix™ during the preceeding year will receive a dose of commercial vaccine and will form the control group of this trial.


Eligibility criteria:
inclusion criteria: * a male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or fluarix during a clinical study organized during the preceeding year exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * history of confirmed influenza infection since a year from the date of previous vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * history of hypersensitivity to vaccines. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
total knee replacement with the attune vs. the press fit condylar (pfc) sigma.

Conditions: Osteoarthrosis, Knee

Summary: 100 knees with primary osteoarthritis and scheduled for a total knee replacement (tkr) will be recruited from our waiting list. the patients will be randomized to become operated with the attune or pfc total knee arthroplasty. randomisation will be done using envelopes. patients can only participate with one knee.

the attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. one of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. thereby the patients are expected to experience improved function, better stability and less pain during activity. so far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the pfc sigma tkr. this study aims to evaluate the clinical outcome and the knee kinematics of the attune knee using recognized clinical outcome parameters and dynamic radiostereometry. the pfc sigma knee will be used as control. 100 knees with primary osteoarthritis and scheduled for a total knee replacement (tkr) will be recruited from our waiting list. the patients will be randomized to become operated with the attune or pfc total knee arthroplasty. randomization will be done using envelopes. patients can only participate with one knee. surgical procedure: the operations will be done according to our routines without use of bloodless field. local analgesia will be infiltrated periarticulary during the operation. cemented fixation will be used in all cases. so-called "fast-track"principles will be applied in both groups. patients will be followed for five years.

Eligibility criteria:
patients with degenerative joint disease of the knee on our waiting list for a total knee replacement will be asked to participate in this study inclusion criteria: * medial or lateral primary osteoarthritis (oa) ahlbäck grade 2-4 * varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees * bmi \<35 * asa 1-3. * coming from independent living in own home * written informed consent exclusion criteria: * cortisone treatment during the last 6 months before operation * neurological diseases with symptoms, stroke with sequel * endocrine diseases with symptoms * oa secondary to trauma, infection, inflammatory disease or congenital and acquired deformities * bmi \>=35 * oa of the hip with symptoms. (patients operated with total hip arthroplasty are accepted) * ongoing infection * unable or unwilling to participate in the follow-up.
a trial to compare prophylaxis therapy to on-demand therapy with a new full length recombinant fviii in patients with severe hemophilia a

Conditions: Hemophilia A

Summary: the objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with bay81-8973 is superior to on-demand therapy with bay81-8973 in patients with severe hemophilia a. the hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.


Eligibility criteria:
inclusion criteria: * male, aged 12 to 65 years * severe hemophilia a * history of more than 150 exposure days (ed) with clotting factor concentrates * currently receiving episodic treatment with fviii; no regular prophylaxis for more than 6 consecutive months in the past 5 years * no current factor viii inhibitor or history of inhibitor * willing to use electronic patient diary exclusion criteria: * presence of another bleeding disease that is different from hemophilia a * thrombocytopenia * abnormal renal function * presence of active liver disease * known hypersensitivity to fviii

Keywords: haemophilia treatment rfviii
outcomes of cesarean section vs vaginal delivery: instrumental variable adjusted analysis

Conditions: Pregnancy Complications; Cesarean Section

Summary: this study will examine the effect of cesarean section on perinatal mortality, using data provided by the canadian institute for health information.

this study will examine administrative data provided by the canadian institute for health information (cihi). maternal obstetrical delivery and neonatal hospitalization records provided by cihi will be linked before analysis. the primary outcome is in-hospital perinatal mortality. the data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the generalized method of moments. the instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. all analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.

Eligibility criteria:
inclusion criteria: * mothers living in canada and their infants delivering within the study period at canadian hospitals outside of the province of quebec. exclusion criteria: * maternal record not linkable to neonatal record. * multiple gestation. * birthweight \< 500 gm. * gestational age at delivery \< 20 weeks. * deliveries at hospitals with less than 20 cesarean deliveries during study period. * records with missing data for important covariates